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To compile characteristics of real-world outcomes for Boston Scientific Corporation's commercially approved Deep Brain Stimulation (DBS) Systems, when used according to the applicable Directions for Use, for the treatment of Essential Tremor.
To compile characteristics of real-world outcomes using Deep Brain Stimulation (DBS) for the treatment of Essential Tremor to add to the evidence available for treatment of ET.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Essential Tremor | Subjects with Essential Tremor being implanted with Boston Scientific Deep Brain Stimulation Systems |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Brain Stimulation Systems (DBS) | Device | Subjects receiving DBS implant for treatment of Essential Tremor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life during the study as compared with baseline using the Quality of Life in Essential Tremor Questionnaire (QUEST) | Change in quality of life over the course of the study using QUEST | Up to 3 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in tremor scores during the study as compared with baseline as assessed by Fahn-Tolosa- Marin Rating Scale | Improvement in tremor scores as assessed by Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) during the study as compared with baseline | Up to 3 years |
| Impression of Change scores during the study using Global Impression of Change |
Inclusion Criteria:
Exclusion Criteria:
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Subjects with Essential Tremor
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Delvaux | Contact | 855-213-9890 | BSNClinicalTrials@bsci.com | |
| Diane Keesey | Contact | 855-213-9890 | BSNClinicalTrials@bsci.com |
| Name | Affiliation | Role |
|---|---|---|
| Natalie Bloom Lyons | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.o. LKH Univ.-Kliniken Innsbruck | Recruiting | Innsbruck | Austria |
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Impression of Change scores during the study using Global Impression of Change |
| Up to 3 years |
| AZ Sint-Lucas | Recruiting | Ghent | Belgium |
|
| UZ Gasthuisberg | Recruiting | Leuven | Belgium |
|
| AZ Delta | Recruiting | Roeselare | Belgium |
|
| Vancouver General Hospital | Recruiting | Vancouver | Canada |
|
| Uniklinik Koln | Recruiting | Cologne | Germany |
|
| Universitaetsklinikum Dusseldorf | Recruiting | Düsseldorf | Germany |
|
| Universitaetsklinikum Essen | Recruiting | Essen | Germany |
|
| Universitatsklinikum Campus Kiel | Recruiting | Kiel | Germany |
|
| Universitaetsklinikum Giessen und Marburg GmbH | Recruiting | Marburg | Germany |
|
| Evangelisches Krankenhaus Oldenburg | Recruiting | Oldenburg | Germany |
|
| Universitaetsklinikum Wuerzburg | Recruiting | Würzburg | Germany |
|
| Medical School of University PECS | Recruiting | Pécs | Hungary |
|
| Policlinico Universitario Agostino Gemelli | Withdrawn | Rome | Italy |
| CHU Sao Joao | Recruiting | Porto | Portugal |
|
| Samsung Medical Center | Recruiting | Seoul | South Korea |
|
| Seoul ASAN Medical Center | Withdrawn | Seoul | South Korea |
| Yonsei University Severance Hospital | Recruiting | Seoul | South Korea |
|
| Hospital De Bellvitge | Recruiting | Barcelona | 30326 | Spain |
|
| Hospital General De Asturias | Recruiting | Oviedo | Spain |
|
| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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